Evaluation of the Efficacy and Safety of Bladder Injection of Autologous Concentrated Platelets in the Treatment of Refractory Overactive Bladder Disorder

OAB is clinically defined by urinary urgency, usually with frequency and nocturia, with or without urgency urinary incontinence, and without a clearly identifiable local pathologic, metabolic, or neurologic cause. OAB can substantially affect daily activities, sleep, social participation, and psychological well-being. Standard treatment options include behavioral interventions, oral antimuscarinic agents, beta-3 adrenergic agonists, and third-line therapies. However, some patients have persistent symptoms after first-line and second-line treatment, or cannot tolerate medication adverse effects. These limitations create a need for additional minimally invasive treatment strategies for refractory OAB.

Autologous platelet concentrate / PRP is derived from autologous blood and contains concentrated platelets and bioactive factors. The biological rationale for PRP includes promotion of tissue repair, modulation of chronic inflammation, and potential effects on local nerve function. Preliminary urologic research has explored PRP in bladder-related disorders such as interstitial cystitis / bladder pain syndrome. Based on these properties, bladder injection of autologous platelet concentrate may have potential to improve refractory OAB symptoms by modulating the bladder wall microenvironment and lower urinary tract function.

This is an investigator-initiated, prospective, single-center observational clinical study conducted in the Department of Urology at The First Affiliated Hospital of Chongqing Medical University. The planned enrollment is approximately 50 adult participants with refractory OAB. The study is a self-initiated project. Participants will be recruited through the urology outpatient clinic. No additional recruitment advertisements are planned. Vulnerable populations, including minors, pregnant women, prisoners, illiterate individuals, and persons without full capacity for civil conduct, will not be enrolled.

Screening includes review of medical history, physical examination, confirmation of OAB diagnosis and refractory status, medication history, pregnancy/lactation status when applicable, OAB symptom and quality-of-life questionnaires, and a 3-day 24-hour bladder diary. Clinical evaluation may include blood routine testing including platelet count, coagulation function, liver and kidney function, blood chemistry, blood glucose, urinalysis, urine culture, urinary tract ultrasound, urodynamic evaluation, and cystoscopy as clinically appropriate. Other diseases that may cause OAB-like symptoms, such as urinary tract infection, bladder stone, bladder tumor, interstitial cystitis / bladder pain syndrome, neurogenic bladder, and bladder outlet obstruction, will be excluded before enrollment.

Eligible participants will undergo bladder injection of autologous platelet concentrate / PRP as clinically arranged. Perioperative information will be recorded, including procedure name, date, operator, procedure duration, blood loss, transfusion if any, intraoperative complications, technical details, vital signs, urination frequency, urine volume, wound or procedure-site status, complications, and all adverse events. According to the ethics resubmission form, participants are expected to participate for approximately 24 weeks and complete four visits: before treatment and at 1, 3, and 6 months after treatment. Participants will complete symptom assessments and clinical-data recording. Approximately 20 mL of blood, approximately 50 mL of urine, and some diseased bladder tissue may be collected according to the study arrangement and clinical need. Study data will be managed using unique coded identifiers to protect participant privacy.